Instruments and method for performing percutaneous surgery

ABSTRACT

A method and apparatus for repairing a defect. The apparatus includes a tubular member, an introducer and a form, wherein, in one embodiment, at least a portion of the form is formed of a biosorbable, shape memory material. The method includes the steps of accessing a percutaneous space adjacent the defect using the tubular member, placing the introducer adjacent the percutaneous space, and conducting tissue repair for the defect through the introducer.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a Continuation-in-Part of U.S. patentapplication Ser. No. 09/466,267, filed on Dec. 17, 1999, which claimspriority to U.S. Provisional Application Serial No. 60/112,928, thesubject matter of both are incorporated herein by reference.

TECHNICAL FIELD

[0002] The present invention relates to methods and apparatus forperforming surgical procedures, particularly minimally invasive surgicalprocedures. More particularly, it involves percutaneous surgicalprocedures and instruments for accomplishing such procedures, whereinembodiments of the invention include percutaneous herniorrhaphy, in someembodiments including mesh reinforcement, and/or gall bladderprocedures.

BACKGROUND

[0003] A hernia is an abnormal protrusion of an organ, tissue, or anyanatomical structure through a forced opening in some part of thesurrounding muscle wall. For example, if a part of the intestine were toprotrude through the surrounding abdominal wall, it would create ahernia—an abdominal hernia. A hernia in the groin area, also called theinguinal region, is known as an inguinal hernia.

[0004] Before a piece of intestine, abdominal cavity tissue, or otherbodily tissue, called a hernial mass, makes its way through a weak spotin the muscle wall, it must first push its way through the peritoneum,which is the membrane that lines the abdomen. The hernial mass, however,does not typically tear and protrude through the peritoneum. Thus, whenthe intestine or hernial mass protrudes, it usually takes the peritoneumwith it and it is covered by the peritoneum. The peritoneal coveringsurrounding the piece of protruding hernial mass is called a hernialSac.

[0005] One known method for hernia repair involves the use of a meshmaterial or patch to line and support the hernial defect. The integrityand longevity of an abdominal wall hernia repair has been increased bythe use of a large segment of mesh whose perimeter extends beyond thevisualized margins of the defect. In one procedure, the segment of meshmay be placed within the preperitoneal space, which is the area locatedbetween the muscle wall and the peritoneum.

[0006] The use of mesh to repair hernial defects was first described andused in open incision medical procedures. Improvements in medicalprocedures have also resulted in the use of mesh in laparoscopicprocedures. The open incision method was typically used as a finalsolution after other methods had failed, because it required a majorincision with lengthy hospitalization for recovery, it causedsignificant post-operative pain, and it required at least a six weekconvalescence to achieve adequate scarring and strength. Thelaparoscopic method has provided improvements because no muscle damagingincision is necessary, only small puncture wounds are used instead ofincisions, it can be done on an outpatient basis, and lesspost-operative pain and convalescence generally results to the patient.Both procedures, however, are operative techniques that require generalanesthesia and can require significant recovery time. Additionally, thedirect cost of the laparoscopic procedure remains considerably highbecause of the equipment that is necessary for the procedure.

[0007] An apparatus and method is needed for improving abdominal wallherniorrhaphy. Furthermore, such an apparatus and method is needed toperform a percutaneous surgical procedure that can reduce the traumaassociated with open incision and laparoscopic procedures.

SUMMARY

[0008] One embodiment of the invention comprises accessing apercutaneous space using a tubular member, using the tubular member toplace an introducer, and conducting tissue repair through theintroducer. The tubular member may be positioned using anatomicallandmarks, and the desired location of the tubular member may beassessed by means of contrast prior to placing a guide wire. After theguide wire is placed, the tubular member may be removed and replacedwith a dilator and an introducer. The dilator is removed, and a form ora balloon is advanced into the preperitoneal space. The balloon's shapemay be varied to approximate the desired shape of the space near adefect to be repaired. The balloon may also function as a carrier of amesh for repairing the defect, and it may be a residual or removableballoon. The method and devices of the invention may be used to repairhernial defects as well as other anatomical defects.

[0009] When the defect is repaired, i.e., the mesh, and/or, in oneembodiment, a curable filling material, is deposited, the stem or guidewire of the tubular member (e.g., catheter), any balloon remnant and theintroducer are removed. Closure of the single puncture and a simpledressing complete the procedure.

[0010] Apparatuses or instruments for the method of the presentinvention include a catheter-like delivery device and a balloon fordelivery thereby. More particularly, the apparatus may include a tubularmember (e.g., catheter, needle trocar or the like), a guide wire, adilator (if required), an introducer and a balloon. The balloon may beof any desired shape and size as long as it passes through the selectedintroducer.

[0011] Other features and advantages of the present invention willbecome more fully apparent and understood with reference to thefollowing description and the accompanying drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012]FIG. 1 is a fragmentary pictorial view of the interior of theabdomen of a patient with viscera removed;

[0013]FIG. 2 is a sectional view of a mesh patch used in accordance withthe present invention inserted into an anatomical defect;

[0014]FIG. 3 is fragmentary view of a portion of the abdomen of apatient;

[0015]FIG. 4 is a perspective view of an introducer used in accordancewith the present invention;

[0016]FIG. 5 is a perspective view of a balloon that may be used inaccordance with the present invention;

[0017]FIG. 6 is a perspective view of an trocar and an obturator passingthrough skin, fat, and muscle;

[0018]FIG. 7 is a perspective view of a form of the invention beingplaced through a trocar;

[0019]FIG. 8 is a perspective view of the placement of the form in oneembodiment of the invention; and

[0020]FIG. 9 is a perspective view of the form after placement to repaira defect.

[0021]FIG. 10 is a perspective view of a guide wire placed through atubular member.

DETAILED DESCRIPTION

[0022] With regard to fastening, mounting, attaching or connecting thecomponents of the present invention to form the apparatus of theinvention, unless specifically described as otherwise, such are intendedto encompass conventional fastening means and methods suitable for usewith metallic, plastic and/or synthetic and natural elastomericmaterials (e.g., threaded members, pins, etc.). Such fastening means andmethods include adhesives, friction fitting, chemical and sonic welding,heating, deformation and the like. Unless specifically otherwisedisclosed or taught, materials for making the components of the presentinvention are selected from appropriate synthetic and naturalelastomeric materials such as silicone, latex, silastic and the like,metal or plastics (e.g., polypropylene or polytetrafluoroethylene).Appropriate forming methods including casting, dipping, extruding,molding and the like may be used.

[0023] Any references herein to front and back, right and left, top andbottom, upper and lower and horizontal and vertical are intended forconvenience of description, not to limit the method or apparatus of thepresent invention or components thereof to any one positional or spacialorientation.

[0024]FIGS. 1 and 2 are provided to depict one field of use of oneembodiment of the present invention, i.e., repair of hernia. FIG. 1shows the interior of the abdomen 10 of a patient with viscera removed,and FIG. 2 shows a form 50 of an embodiment of the invention insertedinto an anatomical defect. The present invention, however, may also beused for any other percutaneous surgical procedures, and it may be usedfor abdominal, thoracic, or diaphragmatic hernia repair, and it may alsobe used for repair of other defects.

[0025] One embodiment of the invention is an apparatus or an instrumentset for performing percutaneous surgical procedures. This apparatus orinstrument set may comprise a tubular member for accessing apercutaneous location and an introducer for placement adjacent to thepercutaneous location. The tubular member may be selected from the groupconsisting of catheters, needles and trocars. In this embodiment, theintroducer may be placed through the tubular member and a selectedpercutaneous surgical procedure may be conducted through the introducer.The tubular member may be positioned using anatomical landmarks to placethe tubular member in the proper space, which may be between theperitoneum and muscle. To aid in placing the tubular member, any methodor device known by interventional radiologists may be used, includinginjection of contrast with either fluoroscopy or imaging technology.Although different introducers may be used within the scope of theinvention, one sample introducer 20 is the longitudinal and tubulardevice depicted in FIG. 4. FIG. 4 also depicts an embodiment of atubular member 20 that may be used as part of the invention, which maybe of a similar shape to the introducer. The apparatus or instrument setmay also include a form 50 for insertion through the introducer, whereina filling material may be deposited adjacent to the form 50. The term“form” will be used in this specification to refer to any patch,balloon, mechanism, material, structure, or body that may be used in asurgical procedure to assist in providing treatment, including to assistin repairing a defect, for placement adjacent a defect to repair or helprepair the defect, or to provide and/or shape a prosthesis for repairinga defect. In one embodiment, at least a portion of the form dissolves oris resorbed, in one embodiment, after a filling material is deposited.In some embodiments, the filling material and/or part or all of the formor prosthesis may be resorbable and/or may be comprised of a shapememory material.

[0026] In one embodiment, the form may comprise a prosthesis 60, whichmay form a patch such as a mesh patch, and a carrier 70 for theprosthesis. In another embodiment, the form 50 may comprise a prosthesis60, such as a mesh patch or any patch known to those skilled in the art,that may be used without a carrier 70. A variety of meshes known tothose skilled in the art may be used within the scope of this inventionfor the prosthesis. See U.S. Pat. No. 5,634,931, issued to Kugel on Jun.3, 1997, and U.S. Pat. No. 5,456,720, issued to Schultz et al. on Oct.10, 1995, which describe various mesh materials and are herebyincorporated by reference into this specification. The Schultz et al.and Kugel patents describe implantable hernia mesh patches that areintended for permanent placement within a patient's body. These meshes,as well as others known to those skilled in the art, repair andreinforce the area of the hernial defect.

[0027] The form 50, also called the access device, may be either hollowor solid and may be either a single piece or multiple pieces. The form50 may also contain directional wires or preset curves. In oneembodiment using a carrier 70 along with a prosthesis 60, the carrier 70may be constructed of biocompatible material. The prosthesis 60 may belocated at or near one end of the carrier 70. The prosthesis 60, whichis the device used to repair the hernial defect, or reinforce a repairof a defect, may be an integral part of the carrier 70 or it may be aseparate piece carried by, attached to or contained within the carrier70. In use, the prosthesis 60 may be detached from the carrier 70 andleft within the hernial defect. The prosthesis 60, therefore, may belocated near or may constitute the leading end of the carrier 70 suchthat it may be deposited in or over the hernial defect. The prosthesis60, contained as a part of the form 50, may be placed within thepreperitoneal space in order to repair the defect.

[0028] In one embodiment, the carrier 70 may be an expandable device ofpredetermined shape with its final volume and size designed to fitwithin the preperitoneal space or to shape a space or area within thepreperitoneal space. One purpose of the carrier 70 is to separate tissueplanes to a size sufficient to contain the prosthesis 60.

[0029] In one embodiment, the carrier 70 may be a balloon, and theprosthesis 60 may be a mesh portion. A variety of balloons known tothose skilled in the art may be used within the scope of the invention;one such balloon is depicted in FIG. 5 with numeral 70. See also U.S.Pat. No. 5,702,416, issued to Kieturakis et al. on Dec. 30, 1997, whichdiscloses a balloon suitable for use with this invention, and isincorporated herein by reference. The mesh portion may either be carriedby the balloon, integrated with the balloon, contained within theballoon, on the outside of the balloon, or may form the structure of theballoon itself. The material forming the prosthesis may be eithercontinuous or perforated, and either permanent or dissolvable. Examplesof materials that may be suitable for the form or prosthesis includestainless steel, polypropylene, polyesters, polytetrafluoroethylene,polyglactin, or polyglycolic acid. The prosthesis may also bereadiopaque or its perimeter may be outlined with radiopaque material.After being deposited adjacent to, within or over the hernial defect,the prosthesis 60 may remain in position, while a portion of it maydissolve. Alternatively, the entire prosthesis may be resorbed or theexpanded prosthesis 60 may be left in place to repair the defect.

[0030] One exemplary material that may be useful in the presentinvention in any of a variety of capacities, e.g., as the prosthesis,balloon, balloon portion, patch, form or a carrier for a prosthesis, orany portion of any of the foregoing items, is a resorbable material. Anexample of such a material is an amorphous copolymer, particularly alactide copolymer, 70:30 Poly(L-lactide-co-D, L-lactide). This materialis made and/or sold by MacroPore Biosurgery, Inc., and sold by MedtronicSofamor Danek under the names MacroPore OS™ and Hydrosorb™. Anothermanufacturer of a suitable material is Collagen Matrix, Inc. The namedamorphous copolymer and/or other suitable materials may be used as animplantable film or mesh, and in some embodiments can be shaped asdesired prior to a procedure, during a procedure or after being placed.There may also be other shape memory materials suitable for use in thepresent invention, e.g., Nitinol or other alloys, thermoplastics such asCalo-MER™, etc., including non-resorbable materials. It should beappreciated that a suitable material may be biosorbable or have shapememory characteristics, or both.

[0031] In operation, the percutaneous surgical procedure for repairing adefect of the present invention may comprise accessing a preperitoneallocation with a tubular member, placing a guide wire through the tubularmember, positioning an introducer over the guide wire, and inserting aform 50 or carrier 70 through the introducer to a position adjacent tothe defect, whereby the carrier 70 serves to repair the defect. The form50 may be collapsed and tightly compacted for advancement through theintroducer and preperitoneal space to the defect. Accessing thepreperitoneal location, which may be deep in the site of the herniawithin the abdominal wall, may be accomplished using anatomic landmarkswhich guide the placement and direction of the tubular member or trocarneedle. Once the guide wire is placed through the tubular member and thetubular member is removed, a dilator may be used to aid in the placementof the introducer. After placement of the introducer, the dilator may beremoved. The carrier 70 may be tightly compacted and/or collapsed duringplacement through the introducer to the hernial defect.

[0032] In one embodiment, the percutaneous surgical procedure maycomprise depositing a filling material through the introducer into thecarrier 70. Once the carrier 70 is placed adjacent to the hernialdefect, air or a liquid or semi-liquid material, such as saline, may beinjected into the carrier 70 via a channel so that the carrier 70 willform a predetermined volume and shape. In some embodiments, the carriermay be shaped by other treatments, e.g., application of temperature(heat or cold), application of chemical(s), or physical manipulation(e.g., cutting, folding, grinding, bending, etc.). In this manner, thecarrier 70 will both define the non-vascular tissue space in which theprosthesis 60 will be placed and it will deposit the prosthesis 60within that space. In this embodiment, the carrier 70, which may be aballoon, may be expanded to approximate the desired shape of the spaceadjacent to the hernial defect, which may be circular, ellipsoid,rectangular, square, or a combination of geometries. In one embodiment,a slurry of biologic and/or plastic material may be used to “set up” tothe shape of the balloon's dimensions, and the balloon may then dissolveleaving a mesh or mass of a desired size an d shape in place. Theprosthesis 60 may be deposited over the hernial defect through use ofthe carrier 70. After being deposited within or over the hernial defect,the prosthesis 60 may remain in position, while a portion or all of itmay dissolve or be resorbed. Alternatively, the expanded or otherwiseshaped prosthesis 60 may be left in place to repair the defect. Inanother embodiment, the prosthesis 60, which may be mesh, will remain inplace to repair the hernia while the carrier 70, which may be a balloon,may dissolve or be withdrawn.

[0033] In another embodiment, the balloon itself may be made of asuitable mesh material on one side with different material suitable forforming a balloon on the other side. After placement of the mesh portionof the balloon over the hernial defect, the nonmesh portion of theballoon could either be removed or could dissolve such that the meshportion of the balloon would remain in place to repair the hernialdefect. Upon completion of placement of the prosthesis over the hernialdefect, the introducer and wire may be removed, along with any portionof the carrier that is not intended to remain within the patient's body.A simple dressing of the skin may then complete the operation. In someembodiments, one or both the non-mesh and mesh portions of the ballooncould be formed by a selected, suitable biosorbable material.

[0034] FIGS. 6-9 depict one embodiment of a method and instruments ofthe invention in use for the placement of a form 50 to repair a defect100. FIG. 6 illustrates a trocar 102 with a sharp obturator 104 passingpercutaneously through the skin 110, fat 120, and muscle 130 of thepatient. The obturator 104 stops before the peritoneum 150 so that thepreperitoneal space 140 may be accessed. In FIG. 7, the obturator 104has been removed and the trocar 102 is in place as it opens thepreperitoneal space 140. A placement rod 106 may be used to place theform 50 in place. The form 50, which may be a carrier 70 with a meshpatch 60 or prosthesis, is shown in a collapsed shape in FIG. 7 passingthrough the trocar 102, and the form 50 may contain a fastener 55 thatattaches the form 50 to the placement rod 106. The fastener 55 may be afriction fit section, a twist section (e.g., threaded, bayonet, etc.),or any type of fastener known to those skilled in the art to removablyattach the form 50 to the placement rod 106. The placement rod 106 may,therefore, have a complementary fastener for attachment to the form 50.

[0035] In FIG. 8, the form 50, which is shown as a balloon or carrier 70with a prosthesis 60 or mesh patch, is being placed over the defect 100.The placement rod 106 is used to position the carrier 70 and prosthesis60 over the defect 100 and between the defect 100 and the peritoneum 150so that the carrier 70 and prosthesis 60 are in the preperitoneal space140. The carrier 70 with prosthesis 60 may then be detached from theplacement rod 106 in any manner known to those skilled in the art. Inone embodiment, a twisting motion may be used to detach the carrier 70with prosthesis 60 from the placement rod 106. The placement rod 106 maythen be removed, along with the trocar 102, and the skin may be closedto complete the procedure so that the defect 100 is repaired. In oneembodiment using a balloon as the carrier 70, the balloon is an integralpart of the mesh patch, which may be used as the prosthesis 60. Theballoon may, in one embodiment, be made of a suitable material so thatit dissolves, and the mesh patch may also be made of a material so thatit dissolves over time. For example, any suitable bio-sorbable material,e.g., the lactide copolymer mentioned above, or the like may be used foreither or both. In other embodiments the balloon may not be dissolvableand/or the mesh patch may not be dissolvable. FIG. 9 illustrates theform 50, which is a carrier 70 and a prosthesis 60 in the depictedembodiment, placed in the preperitoneal space 140 to repair a defect100. The preperitoneal space 140 may be accessed using any method knownto those skilled in the art, such as artificial vision, includingmagnetic resonance imaging (“MRI”) or nuclear magnetic resonance imaging(“NMR”).

[0036] Design examples of the methods of the present invention aredescribed above and herein, along with examples of instruments foraccomplishing the methods. While the present invention has beendescribed with reference to several embodiments thereof, those skilledin the art will recognize various changes that may be made withoutdeparting from the spirit and scope of the claimed invention.Accordingly, this invention is not limited to what is shown in thedrawings and described in the specification but only as indicated in theappended claims. Any numbering or ordering of elements in the followingclaims is merely for convenience and is not intended to suggest that theordering of the elements of the claims has any particular significanceother than that otherwise expressed by the language of the claims.

What is claimed is:
 1. A method for repairing a defect comprising:accessing a percutaneous space adjacent the defect using a tubularmember; placing an introducer adjacent the percutaneous space; andconducting tissue repair for the defect through the introducercomprising inserting a form through the introducer to a positionadjacent the defect, wherein at least a portion of the form comprises abiosorbable material.
 2. The method of claim 1 wherein the formcomprises a carrier and a prosthesis.
 3. The method of claim 2 whereinthe at least a portion of the form is one of the carrier and prosthesis.4. The method of claim 2 wherein the prosthesis is a mesh.
 5. The methodof claim 2 wherein the carrier is a balloon.
 6. The method of claim 1wherein at least a portion of the form has shape memory characteristics.7. An apparatus for performing a percutaneous procedure to repair adefect, comprising: a tubular member for accessing a preperitonealspace; a guidewire for being placed through the tubular member; anintroducer for being positioned over the guidewire; and a form for beinginserted through the introducer to a position adjacent the defect,wherein at least a portion of the form comprises a biosorbable, shapememory material.
 8. The apparatus of claim 7, wherein the form comprisesa balloon and a prosthesis, wherein the prosthesis is resorbable.
 9. Aprocedure for repairing a defect comprising: accessing a percutaneousspace adjacent the defect using a tubular member; placing an introduceradjacent the percutaneous space; and conducting tissue repair for thedefect through the introducer comprising inserting a biosorbablematerial through the introducer to a position adjacent the defect, thebiosorbable material being left in said position after the procedure.10. A method for repairing a hernia comprising: using a tubular memberto create an opening through a muscle wall to a preperitoneal space, theopening and the preperitoneal space being adjacent to a defect in themuscle wall; inserting an introducer through the opening; and insertinga form through the introducer to a position adjacent to a ventralsurface of the defect, wherein the form serves to repair the defect andcomprises a biosorbable material.
 11. The method according to claim 10,wherein the biosorbable material is also a shape memory material.